Recruiting
Early Phase 1

Observational Study

Sponsor:

University of Alabama at Birmingham

Code:

NCT05632562

Conditions

High Grade Glioma

Eligibility Criteria

Sex: All

Age: 10 - 70+

Healthy Volunteers: Not accepted

Interventions

O-(2-[18F]Fluoroethyl)-L-tyrosine, [18F]-FET with PET/MRI

Study Details

Brief summary:

This feasibility study will assess the clinical potential of a new imaging approach to detect viable high grade glioma (HGG) in pediatric and adult patients after standard of care radiation therapy (RT) with or without concurrent temozolomide (TMZ). Study participants will undergo simultaneous positron emission tomography/magnetic resonance imaging (PET/MRI) with O-(\[2-\[F-18\]fluoroethyl)-L-tyrosine (FET, amino acid transport) and 1H-1-(3-\[F-18\]fluoro-2-hydroxypropyl)-2-nitroimidazole (FMISO, hypoxia) at the time of standard of care imaging after completion of RT. The presence of viable tumor at this time point will be assessed on a per patient basis. Study participants will be followed clinically and with standard of care (SOC) imaging for up to 2 years after completion of PET/MRI to determine the nature of lesions seen on investigational imaging and to obtain patient outcome data. The imaging data will also be used to develop a semi-automated workflow suitable for implementation in clinical trials and standard of care PET/MRI studies.

Conditions

High Grade Glioma

Study ID

NCT05632562

Start date

Mar 7, 2024

Status verified date

Aug, 2026

Completion date

Feb 1, 2028

Anticipated

Primary completion date

Feb 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Histologically confirmed newly diagnosed grade III or grade IV glioma treated with standard of care external beam radiation therapy (RT). For diffuse midline glioma involving the pons (diffuse intrinsic pontine glioma), histological confirmation is not required. Surgical resection of the glioma prior to RT and/or concurrent temozolomide (TMZ) with RT are allowed but not required.
2. 10 years of age or older at the time of enrollment
3. Able to undergo PET/MRI without anesthesia or sedation. Minimal sedation with an anxiolytic such as alprazolam used routinely for SOC MRI is allowed.
4. Females with childbearing potential must have a negative urine β-hCG test on the day of procedure or a serum beta-hCG test within 48 hours prior to the administration of FET or FMISO.
5. ECOG performance score of 2 or better in adults. For patients less than 16 years of age, Modified Lansky score ≥ 60.
6. Life expectancy greater than 12 weeks.

Exclusion Criteria:

1. Recurrent glioma
2. Use of bevacizumab or an investigational therapeutic drug for any indication within 3 months prior to the imaging study.
3. Pregnancy or breast feeding
4. Inability to complete PET/MRI scans.
5. Significant renal dysfunction (estimated GFR < 30 mL/min)
6. Any condition which may interfere with ability to participate in or complete all study-related activities as assessed by the study team
7. Time interval greater than 12 weeks between the completion of RT and performance of FET and FMISO PET/MRI studies.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: PET imaging of system L amino acid transport with FET and hypoxia imaging with FMISO

The participant will have a plastic peripheral intravenous (IV) catheter placed in the arm for Positron emission tomography (PET) tracer and MR contrast administration. FET O-(\[2-\[18F\]fluoroethyl)-L-tyrosine and FMISO 1H-1-(3-\[18F\]fluoro-2-hydroxypropyl)-2-nitroimidazole will be produced by the UAB Cyclotron PET Production Facility. PET/MRI will be performed using a GE Signa PET/MRI system in the AIF with specific imaging protocols for FET and FMISO studies. Upon completion of imaging, the peripheral IV catheter will be removed. The participant will be asked to urinate to reduce bladder dose after completion of each PET acquisition.Patients enrolled in the study will be followed clinically and with standard of care brain MRI. PFS and OS will be monitored for up to 24 months after completion of FET and FMISO PET/MRI studies.

Interventions

O-(2-[18F]Fluoroethyl)-L-tyrosine, [18F]-FET with PET/MRI

High grade glioma patients that are planning to undergo radiation therapy (RT) and consent to this study will have up to 3 in-person study visits. The first visit will take up to 2 hours, the second visit will take up to 3 hours, and the third visit will take up to 6 hours. After both imaging visits, there will be a phone call at 24-48 hours after imaging.After confirmation of patient eligibility and consent, the administration of FET and FMISO and related procedures will be performed in the UAB Advanced Imaging Facility (AIF) at the time of first standard of care (SOC) MRI after completion of RT (typically a 4-week interval). Patients enrolled in the study will be followed clinically and with standard of care brain MRI. PFS and OS will be monitored for up to 24 months after completion of FET and FMISO PET/MRI studies. Study participants will not undergo additional study related procedures after completion of the FET-PET/MRI and FMISO-PET/MRI studies.

Primary outcome measure

  • Detection of viable glioma based on PET [ Time Frame: Up to 24 months after completing study PET/MRI visits. ]

Central Contacts and Locations

Central contacts

Sebastian M Eady, BS

205-996-2636smeady@uabmc.edu

Quenteeria S Mooney, BS

205-934-3747qmooney@uabmc.edu

Locations

UAB

Recruiting

Birmingham, Alabama, United States, 35249

Contacts

Sebastian Eady

205-966-2636smeady@uabmc.edu

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-08-20.